Scientific Opinion on Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2): Consideration of genotoxicity data on alicyclic aldehydes with α,β-unsaturation in ring/side-chain and precursors from chemical subgroup 2.2 of FGE.19

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Published on: Wed, 17 May 2017 +0200

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2). In FGE.208Rev1, the CEF Panel evaluated genotoxicity studies on p-mentha-1,8-dien-7-al [FL-no: 05.117], the representative substance for FGE.19 subgroup 2.2. The Comet assay performed in liver showed a positive result, and therefore, the Panel concluded that p-mentha-1,8-dien-7-al [FL-no: 05.117] is genotoxic in vivoand that, accordingly, there is a safety concern for its use as flavouring substance. Since p-mentha-1,8-dien-7-al [FL-no: 05.117] is representative for the nine remaining substances of subgroup 2.2 (p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], myrtenal [FL-no: 05.106], 2,6,6-trimethyl-1-cyclohexen-1-carboxaldehyde [FL-no: 05.121], myrtenyl formate [FL-no: 09.272], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278], myrtenyl acetate [FL-no: 09.302], myrtenyl-2-methylbutyrate [FL-no: 09.899] and myrtenyl-3-methylbutyrate [FL-no: 09.900]), the Panel concluded in the previous revision of FGE.208 (FGE.208Rev1) that there is a potential safety concern for these substances. Subsequently, the industry has submitted genotoxicity studies on five substances of FGE.19 subgroup 2.2: p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], myrtenal [FL-no: 05.106], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278] and myrtenyl acetate [FL-no: 09.302], which are evaluated in the present revision of FGE.208 (FGE.208Rev2). The Panel concluded that the concern for genotoxicity could be ruled out for p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278] and myrtenyl acetate [FL-no: 09.302], which will be evaluated through the Procedure. Genotoxicity data on myrtenal [FL-no: 05.106] were considered equivocal, therefore, it cannot be evaluated through the Procedure, presently. p-Mentha-1,8-dien-7-al [FL-no: 05.117] and four substances not supported by industry (2,6,6-trimethyl-1-cyclohexen-1-carboxaldehyde [FL-no: 05.121], myrtenyl formate [FL-no: 09.272], myrtenyl-2-methylbutyrate [FL-no: 09.899] and myrtenyl-3-methylbutyrate [FL-no: 09.900]) have been deleted from the Union List.